[b][i][color=#FF0000]New[/color][/i][/b] [b]OHRP[/b] [b]Human Research Protection Training[/b] [b]Available![/b] The Office for Human Research Protections (OHRP) just launched the Human Research Protection Training providing foundational knowledge on protecting human subjects in research funded by the U.S. Department of Health and Human Services (HHS). The training was developed for the broad research community including IRBs, investigators and key personnel, and anyone interested in the Common Rule. Access is free and viewers can print a completion certificate upon completing each of the 4 lessons. [b]Check out the online training on OHRP website: [url=https://www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/index.html]www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/index.html[/url][/b] OHRP Division of Education and Development Yvonne Lau Yvonne.Lau@hhs.gov

Human Subject Research: An Insider's View, by Harry C. S. Wingfield, CIP, is now available on Amazon in paperback and Kindle format. https://www.amazon.com/gp/product/B08LF3WZ3J?pf_rd_r=E8NPBAJMM0CESR6S5DE5&pf_rd_p=edaba0ee-c2fe-4124-9f5d-b31d6b1bfbee The book is not necessarily aimed at IRB professionals, but could be a valuable resource for those we work with, including hospital and school administrators, novice investigators, and research participants. Here is a short version of the book description: We all take medicines and get vaccines. Where do these come from? How do they get approved? Why does it take so long to get new medicines? What is “human subjects research?” The short answer is “research that involves people.” There are many claims made about treatments that are coming soon, treatments that need to be made available now, and which treatments work best. In this book, you will learn: • The kinds of human subjects research • What it is like to take part in a research study • Why research participants should be involved in developing research • Why research is done • How research projects are selected • How research participants are protected from harm • Whether you should take part in a research study • How to interpret research study results you see in ads and on the news Harry Wingfield harryw410@gmail.com

The Fall 2020 edition of the Journal of Health and Human Experience (Volume 6, Number 3) has just been published. The new edition is available for free, public access downloads at: http://jhhe.sempervifoundation.org You can download the entire edition (single pages or 2 page spreads), individual articles, and the Table of Contents. For any issues downloading or accessing/viewing the website, contact: info@cryptictruth.com. In addition to free downloads, print-on-demand copies can now be independently purchased directly from the Henry M. Jackson Foundation. All information on this is found on the main web page. The edition includes many articles that have critical importance for many areas including ethics, bioethics, ethics formation and integrity in healthcare and all academic research areas. You will enjoy the edition’s powerful academic articles and commentaries, scholarly explorations, scholarly editorials, insightful reviews, and creative writings. This edition also includes a special international article on research integrity/ethics. In this edition we promote today’s calls for personal, communal, national and global reform and renewal as well as remembering and honoring numerous powerful anniversaries from this year. We honor these memories especially in the edition’s very moving theme: “Reaching Out…for justice…for equality…for health.” And it includes on Cover 2 an honored memorial to Congressman Lewis and Justice Ginsburg. We hope you will visit the website soon and obtain your free copy. Please spread this great news far and wide to all colleagues, friends and institutions/agencies/communities. Most of all — enjoy and be moved! Respectfully, Dr. Edward F. Gabriele Editor-in-Chief & Executive Director Journal of Health & Human Experience Dr. Edward Gabriele egabriele@mac.com

CITI Program and the Association of American Medical Colleges (AAMC) have brought together recognized institutions to contribute and present materials in preparation for the return to campuses. This complimentary course provides an overview of COVID-19, prevention strategies, recommended laboratory practices, and points to consider as students, staff, and faculty move forward to a return to activities and operations within medical school and research institution settings. Supplemental modules focused on topics related to research with human subjects, animal care and use, and working with patients who may be infected or suspected with COVID-19 provide learners the option to review these topics if applicable to their current work or school setting. Visit the CITI Program's [url=https://about.citiprogram.org/en/series/covid-19-back-to-campus/]website[/url] for more information, including how to demo the course as well as request access. Jaime Arango jarango@citiprogram.org

During these uncertain times, institutions need to take advantage of every tool available to maintain and expand their research programs. Our SPIN funding opportunities database contains nearly 40,000 government, foundation, and industry sponsored opportunities that can help. We welcome you to sign up for a free SPIN subscription here: [url=https://spin.infoedglobal.com/signup]https://spin.infoedglobal.com/signup[/url]. We are tracking COVID-19/Coronavirus-related funding opportunities and other types of community resources and making that information available to everyone. Accessing this information does not require a subscription or any kind of registration with InfoEd Global. The information can be accessed via this link: [url=https://www.infoedglobal.com/COVID-19]https://www.infoedglobal.com/COVID-19[/url]. If you have questions or we can help in any way, email us at spinsupport@infoedglobal.com.

PRIM&R has secured additional capacity for today's free webinar, COVID-19: How HRPPs are Preparing and Responding—A Discussion Forum, and we have reopened registration. Register for the live stream here: https://www.primr.org/calendar/webinars/2020/COVID-19-discussion-forum/ (a recording will also be available after the broadcast). Hear from HRPP leaders representing universities, academic health care systems, and an independent IRB on the key issues and strategies HRPPs should be considering and implementing in the face of the COVID-19 pandemic. A significant portion of the webinar will be devoted to open discussion of audience questions and concerns. IRB Forum Admin publicresponsibility@gmail.com

I noticed that someone had posted a request for information on an IRB disaster plan. On March 19th I distributed a complementary issue of my IRB education IRB EasyEd entitled [b][i]Tips for IRB Function During Emergencies[/i][/b]. If you did not receive a copy by email you can download a copy from my website: [url=http://www.apexethical.com]apexethical.com[/url] . Please call or email if you need any help on IRB disaster planning.

Colleagues, The Spring 2020 edition of the Journal of Health and Human Experience (Volume 6, Number 1) has just been published. The new edition is available for free, public access downloads at: http://jhhe.sempervifoundation.org You can download the entire edition (single pages or 2 page spreads), individual articles, and the Table of Contents. For any issues downloading or accessing/viewing the website, contact: info@cryptictruth.com. In addition to free downloads, print-on-demand copies can now be independently purchased directly from the Henry M. Jackson Foundation. All information on this is found on the main web page. The edition includes many articles that have critical importance for many areas including ethics, bioethics, ethics formation and integrity in healthcare and all academic research areas. You will enjoy the edition’s powerful academic articles and commentaries, scholarly explorations, scholarly editorials, insightful reviews, and creative writings. In this edition we promote today’s calls for personal, communal, national and global reform and renewal. One historical moment inspiring us is this year’s 75th anniversary of the Liberation of Auschwitz. We also remember in this edition the beginning of the new 2020 decade and its potentials for us all — inviting us to reflect upon the edition’s very moving theme: “Reclaiming Our 20/20 Vision.” We hope you will visit the website soon and obtain your free copy. Please spread this great news far and wide to all colleagues, friends and institutions/agencies/communities. Most of all — enjoy and be moved! Respectfully, Dr. Edward F. Gabriele Editor-in-Chief & Executive Director Journal of Health & Human Experience Dr. Edward Gabriele egabriele@mac.com

Colleagues, The Fall 2019 edition of the Journal of Health and Human Experience (Volume 5, Number 2) has just been published. The new edition is available for public access downloads (no cost) at: [jhhe.sempervifoundation.org] You can download the entire edition (single pages or 2 page spreads), individual articles, and the Table of Contents. For any issues downloading or accessing/viewing the website, contact: info@cryptictruth.com. The edition includes many articles that have critical importance to ethics formation, leadership development, and diverse explorations that impact the critical nature of research itself: ethics and ethics formation/education/training, research integrity, responsible conduct of research, character formation, regulatory affairs etc. You will enjoy the edition’s powerful academic articles and commentaries, scholarly editorials, insightful reviews, and creative writings. In this edition we honor many anniversaries that move us to consider the vistas and horizons to which we are being called. These special remembrances include the 50th anniversary of Apollo 11 — inviting us to reflect upon the edition’s very moving theme: “One Small Step…..One Giant Leap…..” We hope you will visit the website soon and obtain your free copy. And we welcome you to join there the Journal News Club from which one can receive notices of new editions, calls for manuscripts and other information that may be of interest to you, your colleagues, and your researchers in all fields. Please spread this great news far and wide to all colleagues, friends and institutions/agencies/communities. Most of all — enjoy and be moved! Respectfully, Dr. Edward F. Gabriele Editor-in-Chief & Executive Director Journal of Health & Human Experience Dr. Edward Gabriele egabriele@mac.com

The [b]sIRB Alliance[/b] was formed in 2018 by NYU Langone Health to build consensus on solutions for IRBs who agree to act as an sIRB for NIH-funded, domestic, multi-site research. The sIRB Alliance offers ready-to-implement solutions for policies, procedures and information technology involving multi-site research in efforts to support board adoption of the NIH sIRB model. These solutions were developed through the collaborative efforts of many institutions committed to user-friendly, easily accessible solutions. [b]Who we are[/b] The sIRB Alliance is a group of experts from over 100 research institutions across the country who, through consensus provide solutions for support of sIRB administration. We provide more than just guidance to forming your own independent solutions. Our solutions have gone through an extensive process to build consensus and arrive at a unified approach to sIRB administration. In addition, the sIRB Alliance is building an optimal e-submission platform that allows for effortless data exchange regardless of a participating sites’ e-submission system. [b]What we can do for you[/b] Institutions interested in joining the sIRB Alliance can learn more [url=http://sirballiance.org/]here[/url]. As a member, you will have access to our standardized solutions, as well as future products and consensus building opportunities. Currently, we offer best practice solutions for the following areas: • Informed consent templates • Addendum for Reliance agreement (Addendum to SMART IRB) • Reportable events and non-compliance reporting standards • Ancillary review committees defined • Data Safety Monitoring Charter template • Recruitment Materials review standard • Vulnerable Populations defined [b]Our Goal[/b] Our goal is to facilitate adoption of the sIRB policy while expanding our network of participants and peers to build consensus towards unified solutions. With a larger network, the sIRB Alliance provides institutions of all sizes and means a voice as we continue to build definitive consensus and streamline the sIRB review process. To learn more about the sIRB Alliance you may visit our [url=https://www.sirballiance.org/]website[/url], we look forward to working with you!